PHARM is a private company which provides support to pharmaceutical industries, as well as to private and public research institutes, in all management, organizational, strategic, regulatory, biostatistics, methodological aspects of drug research development, in compliance with applicable regulations and GXPs.
PHARM has established contracts with Pharmaceutical Industries and Research Institutions, and has been subcontractor to manage ethical and regulatory authorisations in a FP7 funded project (DEEP, for the evaluation of a paediatric formulation of deferiprone). This experience in particular acted as a springboard for launching PHARM in a more active role in paediatric research, in line with the primary company’s remit.
PHARM is the Applicant of the PIP (EMEA-001310-PIP01-12) submitted to PDCO for the development of gabapentin in paediatric chronic pain with neuropathic component and will be the Sponsor of the two clinical trials described in WP7 and WP8. PHARM will set up and coordinate all clinical operations for the conduct of GABA-1 and GABA-2, in the framework of WP4. In the experimental clinical setting PHARM will ensure that the standards of good clinical practice will be applied in every recruiting Countries, as well as other applicable national and international regulations and guidelines.
Donato Bonifazi, Economist specialised in Project Management and Project Manager of the FP7 DEEP project. He is involved in the FP7 Projects CloSed, GRIP, NeoMero and NeoVanc. In the GAPP Project he will act as WP4 Leader, the work package aimed at assuring an effective trial management and will act as Sponsor’s Representative.
Mariagrazia Felisi, PhD, degree in Life Sciences, PhD in Clinical Pharmacology and Master in Pharmacovigilance. Dr Felisi is a qualified Person for PharmacoVigilance and has covered for many years the role of Quality Assurance Manager. She is Pharm CEO and its person responsible for EudraVigilance.
Mariapaola Felisi is the Clinical Trial Archivist (CTA) of the GAPP Project and is responsible for administration and trial documentation archiving.
Viviana Giannuzzi, PharmD, PhD in Cellular Biochemistry and pharmacology, post-degree master in clinical research of medicines. She is a researcher, ethical and regulatory expert.
Simona Ravera, data manager with experience in data entry, database management and CRF design. She will be the Clinical Data Manager in the GAPP Project.
Luigina Tagliavacca, Degree in Biological Science, PhD in Molecular Medicine with a Master Degree in Regulatory Affairs. Researcher, medical writer and medical communication. She is expert in Paediatric Investigation Plans (PIPs), relations with ECs and CAs and study start-up. Currently she is WP3 Leader for the GAPP Project and will act as Regulatory Manager.